MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-04-29 for VERISUITE 1.8 manufactured by Medcom Gmbh.
[4436700]
On (b)(4) 2014, medcom has learnt about a software defect related to verisuite 1. 8 version b600. 4. The defect causes malfunctioning of the software when a slice of the planning ct is missing or duplicated. Verisuite will display a message in case of omitted or duplicate slices (a duplicate slice will be omitted). However, when the user continues patient position verification based on ct datasets with duplicate or missing slices, the software defect may lead to a shift of the isocenter position and thus to a wrong correction vector and incorrect patient positioning.
Patient Sequence No: 1, Text Type: D, B5
[11830384]
All affected sites have been contacted on (b)(4) 2014 via a field safety notice (see attached). The field safety notice recommends the user not to continue treatment if verisuite informs about missing slices via an onscreen message, i. E. If the ct dataset was not completely transferred to verisuite. The user shall restart verisuite and reload the complete dataset in case of missing slices. The affected sites are: (b)(4). The sites were also informed in the field safety notice to upgrade as soon as possible to the newest verisuite version 1. 8 b641. 3/. 4, which is available and includes a bug fix for the reported problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006579682-2014-00001 |
| MDR Report Key | 3777371 |
| Report Source | 08 |
| Date Received | 2014-04-29 |
| Date of Report | 2014-04-16 |
| Date of Event | 2014-04-16 |
| Date Mfgr Received | 2014-04-16 |
| Device Manufacturer Date | 2011-12-09 |
| Date Added to Maude | 2014-06-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. LUCA SALVATORE |
| Manufacturer Street | RUNDETURMSTR. 12 |
| Manufacturer City | DARMSTADT, HESSEN 64283 |
| Manufacturer Country | GM |
| Manufacturer Postal | 64283 |
| Manufacturer Phone | 1519514718 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERISUITE 1.8 |
| Generic Name | PARTICLE THERAPY - PATIENT POSITIONING VERIFICATION SOFTWARE |
| Product Code | LHN |
| Date Received | 2014-04-29 |
| Model Number | 1.8 |
| ID Number | B600.4 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDCOM GMBH |
| Manufacturer Address | RUNDETURMSTR. 12 DARMSTADT, HESSEN 64283 GM 64283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-29 |